FDA Recall of the HeartMate 3™

The FDA has posted another recall of a medical device. This particular recall is a Class I recall, the highest level recall there is, and concerns a medical device that goes in patients’ hearts; the HeartMate 3™ Left Ventricular Assist System. according to the FDA, “It is used for short-term support of patients who are at risk of death from end-stage left ventricular heart failure, such as patients awaiting a heart transplant.”

These devices that are on the market – on shelves and in patients – may malfunction and cause “the outflow graft to twist and close up (occlusion) over time.” This malfunction can lead to less pump flow, which in turn can cause serious injuries, including blood clots and death.

From the FDA’s Recall Page, here is more information:

• Recalled Products: HeartMate 3™ Left Ventricular Assist System
• Model/Item Numbers: Catalog # 106524US (U.S. commercial), 106524 (U.S. Investigational Device Exemption number), 10652INT (international)
• Lot Numbers: All lots
• Manufacturing Dates: All
• Distribution Dates: September 2, 2014, to present
• Devices Recalled in the U.S.: 4,878 units nationwide

People who have been injured by a malfunctioning product should be able to sue the company that manufactured the product, and possibly the company that sold it. We expect companies to make products that work as intended and that work safely. However, that is not the case with some medical devices, and usually are the ones that are used in critical ways, like the HeartMate3.

This oversight is due to the way a medical device gets approved by the FDA. There are two ways a medical device gets to physicians through the FDA – what we call the 510(k) clearance pathway and through a Pre Market Approval (PMA). Devices that the FDA approves through a PMA are generally preempted from lawsuits. What that means is, if you get hurt, we are unable to obtain compensation for you.

However, there are exceptions to this rule. For example, Bayer has sold a “permanent” contraceptive medical device to women called, Essure. Like the HeartMate 3™ Left Ventricular Assist System discussed here, Essure was approved by the FDA. But after that approval in 2002, thousands of women suffered horrible injuries allegedly from the device.

Even though the preemption law applied to Essure, attorneys were able to convince a Court in California (among other courts) to let lawsuits continue. One of the prevailing theories was that the company, Conceptus, which Bayer later bought, had more adverse effects that it didn’t report to the FDA. They include incidents where the product may have caused a severe injury. More adverse side effects surfaced after the FDA approved the device, but the company failed to report those adverse events to the FDA. As a result, we get to continue trying to hold the company accountable for allegedly violating the law and hurting any consumers.

I am lucky enough to be a part of the Essure litigation. I serve on the Plaintiffs’ Steering Committee (PSC), which is a group of plaintiffs’ lawyers working on the pretrial and ultimately trial work in the litigation. We’re in the middle of discovery and expert work in the Essure litigation, after years of legal battles.

If you or a loved one has a HeartMate3 device, make sure to check out the FDA’s recall notice. Do not make any dramatic medical changes without speaking to a licensed physician first. If you believe you may have had complications with your device, contact us today.

Justin Browne, Esq.
Partner